Celcuity (CELC) investor relations material

Product pipeline and approvals

• Lead candidate REVTORPYK, a pan PI3K/mTORC1/2 inhibitor, is approved for second-line HR-positive, HER2-negative advanced breast cancer, with launch planned this quarter.

• Two phase III studies are ongoing in first-line HR-positive breast cancer, targeting both endocrine-sensitive and endocrine-resistant patients.

• An additional early-stage study in prostate cancer is underway, with updated results expected by year-end.

• NDA for PIK3CA mutant breast cancer was filed last year; review and potential approval are anticipated in the second quarter.

• Expanded access program is active for eligible patients, but volumes are not reflected as sales.

Commercial launch and market access

• Launch preparations began 2.5 years ago, including building a 90-person oncology sales force and engaging payers and strategic accounts.

• Significant awareness has been created among both academic and community oncologists, who treat about 80% of breast cancer patients.

• Market access teams have worked with payers for 18 months, and groundwork with clinical pathway influencers is ongoing.

• Second manufacturing site is being validated for additional capacity, with plans to have four validated manufacturers by 2027.

• Expanded access program provides the drug free of charge until commercial availability, after which patients will transition to commercial product.

Product positioning and clinical strategy

• Two approved regimens (doublet and triplet) allow flexibility for physicians to tailor treatment; expected usage split is about 80/20 in favor of the triplet.

• Regimens are highly differentiated in efficacy and safety for most patient subgroups, with competitive positioning even in ESR1 mutant populations.

• Real-world duration on therapy may exceed clinical trial results due to broader patient eligibility.

• Time to peak sales is expected to be 36-42 months for a first-launch company, longer than for established pharma.

• Payer access for off-label use in PIK3CA mutant population may depend on NCCN guideline updates.